MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE D; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924)

Event Date 06/07/2023

Event Type  Injury  

Event Description

It was reported that a patient was revised approximately one year and three months post implantation due to the tibia implant being too small and it subsided and caused early failure and possible infection as a specimen sent came back with staph.Attempts to obtain additional information have been made; however, no more information is available.

Manufacturer Narrative

(b)(4) d10-medical product femur trabecular metal (cr) standard porous item# 42502806201 lot# 64946899 articular surface (mc) left 12 mm height item# 42512100412 lot# 63897270 all-poly patella cemented 32 mm diameter item# 42540200032 lot# 65140172 g2- australia h3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, and h10 no product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined for the subsidence noted.The infection noted was determined to be not device related.This complaint could not be confirmed by the information provided.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE D
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17277193
• MDR Text Key: 318556464
• Report Number: 0001822565-2023-01823
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530006701
• Device Lot Number: 65000396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 06/07/2023; 10/24/2023
• Supplement Dates FDA Received: 08/02/2023; 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 102 KG